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Cancer Vaccine
HZ/su Vaccine for Shingles
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48
Awards & highlights
Study Summary
This trial will assess the long-term efficacy, immunogenicity, and safety of the herpes zoster subunit vaccine in older adults.
Who is the study for?
This trial is for older adults who previously participated in the ZOSTER-049 study and received at least one dose of the HZ/su vaccine. They must be medically stable, able to follow the study's procedures, and have given informed consent. Those currently using or planning to use unregistered treatments for shingles or chickenpox, with conditions posing additional risks, or participating in other studies on such infections cannot join.Check my eligibility
What is being tested?
The study is examining the long-term effectiveness and safety of the HZ/su vaccine against shingles up to approximately 11-15 years after initial vaccination. It also looks at how long immune responses last and assesses safety following one or two extra doses given about five years later.See study design
What are the potential side effects?
While specific side effects are not listed here, vaccines like HZ/su may cause reactions where injected (pain, redness), general symptoms like fever, fatigue, headaches as well as muscle pain. Serious side effects are rare but will be monitored throughout this long-term study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1-month post-dose 2 in the zoster-006/022 studies until the end of the zoster-101 study at month 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Anti-glycoprotein E (gE) antibody concentrations
Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L
Number of participants in LTFU and Control groups with confirmed HZ cases
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Revaccination GroupExperimental Treatment1 Intervention
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Group II: LTFU GroupExperimental Treatment1 Intervention
Participants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study.
Group III: Control GroupExperimental Treatment1 Intervention
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study.
Group IV: 1-Additional Dose GroupExperimental Treatment1 Intervention
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HZ/su vaccine
2014
Completed Phase 1
~160
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,064,434 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,140,892 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not in another study that involves treatment or prevention for HZ or VZV.I have been vaccinated or plan to be vaccinated against shingles or chickenpox.I am not using and do not plan to use any experimental treatments for shingles or chickenpox during the study.You have already participated in the ZOSTER-049 study or received at least one dose of HZ/su in the ZOSTER-006/022 studies.
Research Study Groups:
This trial has the following groups:- Group 1: 1-Additional Dose Group
- Group 2: Revaccination Group
- Group 3: Control Group
- Group 4: LTFU Group
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers will be enrolled in this research project?
"The clinical trial is still recruiting patients, as mentioned on the website clinicaltrials.gov. This specific study was posted on 8/10/2022 and was last edited on 11/2/2022. Enrollment for this trial is looking for 3662 participants from 3 locations."
Answered by AI
Is there a high rate of adverse effects associated with this medication?
"This treatment received a score of 3 for safety because it is a Phase 3 trial. This means that, in addition to some efficacy data, there are also multiple rounds of safety data."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Interested in vaccine.
PatientReceived 2+ prior treatments
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